ANIFROLUMAB ( DrugBank: Anifrolumab )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ2
49全身性エリテマトーデス38

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 185 - 標的パスウェイ数 : 223
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03435601
(ClinicalTrials.gov)
April 18, 201831/1/2018A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)A Randomised, Double-blind, Placebo-controlled Phase II Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)Rheumatoid ArthritisDrug: Anifrolumab;Drug: PlacebosJosef Smolen, Univ. Prof. Dr.NULLRecruiting18 Years70 YearsAll24Phase 2Austria
2EUCTR2017-001717-92-AT
(EUCTR)
11/12/201717/08/2017A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA)A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA High IFN siganture in patients with rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab (MEDI-546)
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: ANIFROLUMAB
Medical University of ViennaNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Italy;Switzerland;Austria

49. 全身性エリテマトーデス


臨床試験数 : 946 薬物数 : 722 - (DrugBank : 186) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 198
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2071210076
01/11/202115/10/2021A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusThe purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy - Tulip SC Systemic Lupus ErythematosusApproximately 360 patients are planned to be randomly assigned in a 1:1 ratio (180 patients
per treatment group) to receive either a fixed SC dose of anifrolumab or placebo once weekly (QW).
Hibi KazushigeNULLRecruiting>= 18age old<= 70age oldBoth36Phase 3United States;Argentina;Bulgaria;Chile;Colombia;Hungary;Mexico;Peru;Poland;Russia;Ukraine;United Kingdom;Germany;Spain;Japan
2NCT04931563
(ClinicalTrials.gov)
September 13, 202129/4/2021Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: placeboAstraZenecaNULLRecruiting18 Years70 YearsAll328Phase 3China;Hong Kong;Korea, Republic of;Philippines;Taiwan;Thailand
3EUCTR2020-004529-22-BG
(EUCTR)
10/09/202123/07/2021Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC Moderate-to-severe Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: ANIFROLUMAB
AstraZenecaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Peru;Bulgaria;Germany;Japan
4EUCTR2020-004529-22-HU
(EUCTR)
24/08/202118/06/2021Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus ErythematosusA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC Moderate-to-severe Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: ANIFROLUMAB
AstraZenecaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Spain;Ukraine;Chile;Russian Federation;Colombia;United Kingdom;Hungary;Mexico;Japan;Germany;Bulgaria;Peru;Poland;Argentina
5NCT05001698
(ClinicalTrials.gov)
July 27, 202130/6/2021Anifrolumab PK Study for Systemic Lupus Erythematosus (SLE)A Phase I, Open-label, Single-Arm, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Anifrolumab in Chinese Participants With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: AnifrolumabAstraZenecaNULLActive, not recruiting18 Years60 YearsAll15Phase 1China
6NCT04750057
(ClinicalTrials.gov)
July 1, 20219/2/2021Anifrolumab Early Access ProgramAn Early Access Program for Anifrolumab Treatment in Adult Patients With Active Systemic Lupus Erythematosus - AMANASystemic Lupus ErythematosusDrug: AnifrolumabAstraZenecaClinigen, Inc.No longer available18 YearsN/AAllNULL
7NCT04877691
(ClinicalTrials.gov)
June 8, 20214/5/2021Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusA Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Medi-546;Drug: PlaceboAstraZenecaIqvia Pty LtdRecruiting18 Years70 YearsAll360Phase 3United States;Argentina;Bulgaria;Chile;Colombia;Germany;Hungary;Japan;Mexico;Peru;Poland;Russian Federation;Spain;Ukraine;United Kingdom
8NCT04726553
(ClinicalTrials.gov)
January 20, 202122/1/2021Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLENature of Anifrolumab Impact on Vaccine-Emergent Immunity in Patients With Moderately to Severely Active Systemic Lupus Erythematosus: A Multi-Centre Open Label Parallel Group Trial:Systemic Lupus Erythematosus (SLE)Drug: Anifrolumab;Drug: Standard of CareOklahoma Medical Research FoundationNYU Langone Health;Yale University;Piedmont Heart Institute, Inc., Atlanta, GA;Columbia UniversityRecruiting18 Years70 YearsAll20Early Phase 1United States
9EUCTR2016-000625-39-BG
(EUCTR)
17/05/201708/03/2017A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
10JPRN-JapicCTI-173544
26/4/201723/03/2017TULIP SLE LTEA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus Active Systemic Lupus ErythematosusIntervention name : Anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
AstraZenecaNULLcomplete18BOTH50Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania
11NCT02962960
(ClinicalTrials.gov)
February 14, 201723/9/2016A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin ManifestationsA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.Systemic Lupus ErythematosusDrug: Anifrolumab;Drug: PlaceboAstraZenecaNULLCompleted18 Years70 YearsAll36Phase 2United States;Hungary;Korea, Republic of;Poland
12EUCTR2016-003246-93-PL
(EUCTR)
26/01/201713/12/2016A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer
Astrazeneca ABNULLNot RecruitingFemale: yes
Male: yes
32Phase 2United States;Hungary;Poland;Korea, Republic of
13EUCTR2016-000625-39-DE
(EUCTR)
13/12/201605/07/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan
14EUCTR2016-003246-93-HU
(EUCTR)
06/12/201619/10/2016 The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms. A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Anifrolumab
Product Code: MEDI-546
Astrazeneca ABNULLNot Recruiting Female: yes
Male: yes
32 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Poland;Korea, Republic of
15EUCTR2016-000625-39-LT
(EUCTR)
03/11/201617/08/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan
16EUCTR2016-000625-39-ES
(EUCTR)
24/08/201615/07/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
17EUCTR2016-000625-39-HU
(EUCTR)
18/08/201623/06/2016A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
575Phase 3United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
18NCT02794285
(ClinicalTrials.gov)
June 30, 20166/6/2016Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.Active Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: PlaceboAstraZenecaPRA Health SciencesCompleted18 Years70 YearsAll559Phase 3United States;Argentina;Australia;Bulgaria;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Brazil;Czech Republic;Czechia;Italy;New Zealand;Singapore
19JPRN-JapicCTI-153064
27/4/201611/11/2015TULIPA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus Active Systemic Lupus ErythematosusIntervention name : anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Intravenous infusion (IV)
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Intravenous infusion (IV)
AstraZenecaNULLcomplete1870BOTH60Phase 3Japan, Asia except Japan, North America, South America, Europe, Africa
20EUCTR2014-004632-19-BG
(EUCTR)
11/12/201527/10/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
21EUCTR2014-004633-96-RO
(EUCTR)
26/11/201508/10/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
22EUCTR2014-004632-19-DE
(EUCTR)
12/11/201506/08/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;South Africa;Germany;Korea, Republic of
23EUCTR2014-004633-96-DE
(EUCTR)
12/11/201528/05/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Brazil;Poland;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of
24EUCTR2014-004633-96-PL
(EUCTR)
14/10/201505/08/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of
25EUCTR2014-004632-19-CZ
(EUCTR)
23/09/201528/07/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
26EUCTR2014-004632-19-ES
(EUCTR)
21/09/201524/06/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
27EUCTR2014-004633-96-IT
(EUCTR)
16/09/201521/01/2020A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - NA Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
Product Code: NA
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
Product Code: NA
INN or Proposed INN: Anifrolumab
ASTRAZENECA ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noKorea, Republic of;New Zealand;Germany;Australia;Peru;Romania;Brazil;Poland;Argentina;Hungary;United Kingdom;Italy;Colombia;Israel;Chile;Ukraine;Taiwan;United States
28EUCTR2014-004632-19-BE
(EUCTR)
07/09/201523/06/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
29EUCTR2014-004633-96-HU
(EUCTR)
02/09/201529/06/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
30EUCTR2014-004632-19-LT
(EUCTR)
20/08/201519/06/2015A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
31EUCTR2014-004633-96-GB
(EUCTR)
16/07/201508/05/2015A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
32NCT02446899
(ClinicalTrials.gov)
July 9, 201514/5/2015Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: PlaceboAstraZenecaPRA Health SciencesCompleted18 Years70 YearsAll373Phase 3United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore
33NCT02446912
(ClinicalTrials.gov)
June 9, 201514/5/2015Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusA Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusBiological: Anifrolumab;Drug: PlaceboAstraZenecaPRA Health SciencesCompleted18 Years70 YearsAll460Phase 3United States;Argentina;Australia;Brazil;Chile;Colombia;Germany;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Taiwan;Ukraine;United Kingdom
34EUCTR2012-004619-30-BG
(EUCTR)
09/05/201407/03/2014A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus ErythematosusA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
MedImmune, LLC, a wholly owned subsidiary of AstraZenecaNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Colombia;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
35EUCTR2012-004619-30-CZ
(EUCTR)
29/08/201319/06/2013A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus ErythematosusA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
MedImmune, LLC, a wholly owned subsidiary of AstraZenecaNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBulgaria;Korea, Republic of;Peru;Romania;Poland;Brazil;Mexico;Hungary;Czech Republic;Colombia;Ukraine;Taiwan;United States
36EUCTR2012-004619-30-HU
(EUCTR)
27/08/201328/06/2013A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
Product Name: anifrolumab
Product Code: Medi-546
INN or Proposed INN: anifrolumab
MedImmune, LLC, a wholly owned subsidiary of AstraZenecaNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Taiwan;Ukraine;Colombia;Hungary;Czech Republic;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Korea, Republic of
37NCT01753193
(ClinicalTrials.gov)
March 28, 201317/12/2012An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in AdultsA Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus ErythematosusLupus Erythematosus, SystemicBiological: AnifrolumabMedImmune LLCNULLCompleted18 Years68 YearsAll218Phase 2United States;Brazil;Bulgaria;Colombia;Czechia;Hungary;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Czech Republic
38NCT01438489
(ClinicalTrials.gov)
January 20129/9/2011A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus ErythematosusA Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: PlaceboMedImmune LLCNULLCompleted18 Years65 YearsAll626Phase 2United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong